FDA Import Alert Removal

Import Alerts are put on products and manufacturers that appear to be in violation of the Food and Drug Administration’s laws and guidelines. Once a manufactur/product is placed on Import Alert your products will automatically be detained without physical examination. Importers importing the product should always check if a Manufactuer is on import alert to avoid any last minute suprises. 

There are 4 purposes to FDA Import Alerts: 

1. Prevent potentially violative products from being distributed in the United States.
2. Free-Up FDA Resources to examine other potentially violative shipments.
3. Ensure that divisions of the FDA across the United States are on the same page on violative manufacturer’s and their products.
4. Place the responsibnility on the importer to ensure that the products being imported into the United States are in compliance with the FDA Laws and Guidelines.

To become eligble to remove a Import Alert you must comply with the FDA’s rules on doing so. First part to remove a import alert is to ensure 5 shipments have been cleared safe and released by the FDA. Once that has been done we can help you create the petition of Import Alert Removal which consists of many components proving to the FDA that your company product is now in compliance.

“FDA Registration Assistance” can assist through out the whole process. If you would like to learn more about Import Alert Removal please CONTACT US.